دورية أكاديمية
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Prolonged Pharmacokinetic Interaction Between Capecitabine and a CYP2C9 Substrate, Celecoxib.

التفاصيل البيبلوغرافية
العنوان: Prolonged Pharmacokinetic Interaction Between Capecitabine and a CYP2C9 Substrate, Celecoxib.
المؤلفون: Ramírez J; Department of Medicine, University of Chicago, Chicago, IL, USA., House LK; Department of Medicine, University of Chicago, Chicago, IL, USA., Karrison TG; Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.; Comprehensive Cancer Center, University of Chicago, Chicago, IL, USA., Janisch LA; Department of Medicine, University of Chicago, Chicago, IL, USA., Turcich M; Department of Medicine, University of Chicago, Chicago, IL, USA., Salgia R; Department of Medicine, University of Chicago, Chicago, IL, USA.; Comprehensive Cancer Center, University of Chicago, Chicago, IL, USA., Ratain MJ; Department of Medicine, University of Chicago, Chicago, IL, USA.; Comprehensive Cancer Center, University of Chicago, Chicago, IL, USA.; Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, Chicago, IL, USA., Sharma MR; Department of Medicine, University of Chicago, Chicago, IL, USA.; Comprehensive Cancer Center, University of Chicago, Chicago, IL, USA.; Committee on Clinical Pharmacology and Pharmacogenomics, University of Chicago, Chicago, IL, USA.
المصدر: Journal of clinical pharmacology [J Clin Pharmacol] 2019 Dec; Vol. 59 (12), pp. 1632-1640. Date of Electronic Publication: 2019 Jul 05.
نوع المنشور: Clinical Trial; Journal Article; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2013- : Oxford : Wiley
Original Publication: Stamford, Conn., Hall Associates.
مواضيع طبية MeSH: Capecitabine/*pharmacokinetics , Celecoxib/*pharmacokinetics , Cytochrome P-450 CYP2C9/*metabolism, Adult ; Aged ; Aged, 80 and over ; Area Under Curve ; Drug Interactions/physiology ; Female ; Humans ; Male ; Middle Aged
مستخلص: This study investigated the time course and magnitude of the pharmacokinetic interaction between capecitabine and the cytochrome P450 (CYP) 2C9 substrate celecoxib, with implications for coadministration of fluoropyrimidines with CYP2C9 substrates such as warfarin. Patients received celecoxib 200 mg orally twice daily continuously, with capecitabine (1000 mg/m 2 orally twice daily for 14 days every 21 days) starting 7 days later. Assessment of the drug-drug interaction (DDI) potential was performed using equivalence testing, which assumes that there is no clinically relevant DDI when the calculated 90% confidence intervals (CIs) of the drug exposure ratios fall within the range of 0.80 to 1.25. Comparison of steady-state pharmacokinetic parameters of celecoxib between day 7 (cycle 0, celecoxib only) and day 14 (cycle 1, celecoxib + capecitabine) showed geometric mean ratios of 1.24 (90%CI, 1.04-1.49), 1.30 (1.11-1.53) and 1.28 (1.11-1.47) for maximum plasma concentration, minimum plasma concentration, and area under the concentration-time curve from time zero to 8 hours, respectively. Comparison of day 7 vs day 21 (cycle 1, after 1 week washout of capecitabine) showed a further increase in the geometric mean ratio of maximum plasma concentration (1.39; 90%CI, 1.16-1.66), minimum plasma concentration (1.53; 1.10-2.12) and area under the concentration-time curve from time zero to 8 hours (1.41; 1.19-1.68). Because the 90%CIs fell outside the prespecified equivalence margin, we conclude that coadministration results in a DDI (increased celecoxib exposure) that persists for at least 7 days after capecitabine discontinuation. Close monitoring should be undertaken when administering fluoropyrimidines with CYP2C9 substrates with narrow therapeutic indexes while also weighing the benefits and risks for individual patients.
(© 2019, The American College of Clinical Pharmacology.)
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معلومات مُعتمدة: U01GM061393 United States GM NIGMS NIH HHS; K12CA139160 United States CA NCI NIH HHS; P30 CA14599 United States CA NCI NIH HHS
فهرسة مساهمة: Keywords: CYP2C9; capecitabine; celecoxib; drug-drug interaction; pharmacokinetics
المشرفين على المادة: 6804DJ8Z9U (Capecitabine)
EC 1.14.13.- (CYP2C9 protein, human)
EC 1.14.13.- (Cytochrome P-450 CYP2C9)
JCX84Q7J1L (Celecoxib)
تواريخ الأحداث: Date Created: 20190706 Date Completed: 20200819 Latest Revision: 20200819
رمز التحديث: 20221213
DOI: 10.1002/jcph.1476
PMID: 31274208
قاعدة البيانات: MEDLINE
الوصف
تدمد:1552-4604
DOI:10.1002/jcph.1476